围术期应用亮丙瑞林治疗子宫腺肌病的系统评价  

Systematic evaluation of perioperative application of leuprolide for adenomyosis

作　　者：曹美灵 桂涛[1,2] 黄美华[1,2] 朱利[1,2] 甘霖[1] 王智慧[3] 陈燕[3] 万贵平[1,2] CAO Meiling;GUI Tao;HUANG Meihua;ZHU Li;GAN Lin;WANG Zhihui;CHEN Yan;WAN Guiping(Affiliated Hospital of Integrated Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing 210028,China;Jiangsu Province Academy of Traditional Chinese Medicine,Nanjing 210028,China;Suzhou Xiangcheng People’s Hospital,Suzhou 215131,China)

机构地区：[1]南京中医药大学附属中西医结合医院,江苏南京210028 [2]江苏省中医药研究院,江苏南京210028 [3]苏州市相城人民医院,江苏苏州215131

出　　处：《药物评价研究》2022年第12期2555-2563,共9页Drug Evaluation Research

基　　金：国家自然科学基金青年基金资助项目(81403321);江苏省中医药科技发展专项(2020ZX14);江苏省中医药科技发展计划项目(YB2020018);南京市玄武区兰园社区服务中心工作站建设项目(18-G2S-G22-003)。

摘　　要：目的 系统评价保守性手术围术期应用亮丙瑞林治疗子宫腺肌病(AM)的临床有效性和安全性。方法 检索Cochrane Library、PubMed、Web of Science、Embase、ClinicalTrials.gov、中国临床试验注册中心(ChiCTR)、中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、维普中文期刊全文数据库(VIP)和中国生物医学文献数据库(CBM),搜集围术期应用亮丙瑞林治疗AM的临床随机对照试验(RCT),检索时限为各数据库建库至2022年1月8日,两位研究者独立进行文献筛选、偏倚风险评价和资料提取,采用ReviewManager 5.4.1软件进行Meta分析。结果 共纳入11项RCTs、包括1 088例患者。Meta分析结果显示:术前应用亮丙瑞林能够减轻术后3个月痛经[SMD=-1.61,95%CI(-2.60,-0.63),P=0.001],减小术后3个月月经量[SMD=-1.02,95%CI(-1.43,-0.60),P<0.000 01]和术后12个月月经量[SMD=-1.07,95%CI(-1.36,-0.79),P<0.000 01],两组术后12个月痛经[SMD=-2.88,95%CI(-5.89,0.13),P=0.06]差异无统计学意义;术后应用亮丙瑞林能够减轻术后3个月痛经[SMD=-2.94,95%CI(-3.59,-2.29),P<0.000 01]和12个月痛经[SMD=-1.53,95%CI(-2.51,-0.55),P<0.000 01],减小术后3个月月经量[SMD=-0.62,95%CI(-1.06,-0.18),P=0.006]和12个月月经量[SMD=-7.93,95%CI(-9.12,-6.74),P<0.000 01],差异有统计学意义。结论 术前应用亮丙瑞林可以提高手术安全性和有效率、促进术后康复,术后短期应用亮丙瑞林疗效显著并能够减少复发,术前或术后应用亮丙瑞林均可能出现药品不良反应,尚需开展更多高质量研究予以验证。Objective To systematically evaluate the clinical efficacy and safety of perioperative leuprolide application in conservative surgery for adenomyosis(AM).Methods Cochrane Library,PubMed,Web of Science,Embase,ClinicalTrials.gov,ChiCTR,CNKI,WanFang Data,VIP and CBM for related randomized controlled trials(RCTs) published before 8 January 2022were searched.Two reviewers independently screened literature,assessed the risk of bias,and extracted data of included studies.Then meta-analysis was performed using ReviewManager 5.4.1 software.Results A total of 11 RCTs involving 1 088 patients were included.Compared with simple conservative surgical therapy,preoperative leuprolide application can moderate postoperative dysmenorrhea at 3rd month [SMD =-1.61,95%CI(-2.60,-0.63),P = 0.001],reduce menstrual flow at 3rd month [SMD =-1.02,95%CI(-1.43,-0.60),P < 0.000 01] and at 12th month [SMD =-1.07,95%CI(-1.36,-0.79),P < 0.000 01],the difference was statistically significant.There was no significant difference in dysmenorrhea at 12th months [SMD =-2.88,95%CI(-5.89,0.13),P = 0.06] between the two groups after surgery;postoperative leuprolide application can moderate postoperative dysmenorrhea at3rd month [SMD =-2.94,95%CI(-3.59,-2.29),P < 0.000 01] and at 12th month [SMD =-1.53,95%CI(-2.51,-0.55),P < 0.000 01],reduce menstrual flow at 3rd month [SMD =-0.62,95%CI(-1.06,-0.18),P = 0.006] and 12th month [SMD =-7.93,95%CI(-9.12,-6.74),P < 0.000 01].Conclusions Preoperative leuprolide application safely improve the surgical efficacy and promote rehabilitation,short-term postoperative application of leuprolide has significant efficacy and can reduce recurrence,adverse drug reactions may occur in both protocols.More high-quality studies are required to verify the above conclusions.

关 键 词：亮丙瑞林 子宫腺肌病 保守性手术 痛经 系统评价 META分析 

分 类 号：R984[医药卫生—药品] R969.3[医药卫生—药学]